Afirma Thyroid FNA Analysis

The Evolved Solution for Improved Thyroid Nodule Assessment

Indeterminate* results on thyroid FNA samples are a common and significant problem for physicians and their patients. FNA samples can be challenging to interpret and produce inconclusive results in up to 30 percent of cases.1 Current guidelines recommend that most of these patients go to surgery.2-3 However, the majority of these cases end are diagnosed as benign by surgical pathology.1 Now, the Afirma Thyroid FNA Analysis delivers physicians an improved solution to better assess thyroid nodules.4-6  The Afirma Thyroid FNA Analysis combines expert cytopathology and the novel Afirma Gene Expression Classifier.

The Afirma Thyroid FNA Analysis begins with a thorough cytopathological evaluation by an expert at Thyroid Cytopathology Partners (TCP), an independent laboratory partner of Veracyte. Typically, a Patient Report can be issued based on cytopathology assessment alone with a final benign, suspicious or malignant diagnosis. When TCP's cytopathology assessment yields an indeterminate* diagnosis, Veracyte's proprietary Gene Expression Classifier is performed with the goal to pre-operatively identify benign nodules so that physicians can more confidently choose to follow patients instead of recommending diagnostic thyroidectomy.4-8 Since implementing Afirma into their practice, physicians have reduced the number of surgeries approximately in half.8

The Gene Expression Classifier was developed  through  rigorous science to identify benign nodules, which were initially diagnosed by cytopathology as indeterminate. Two prospective, independent, multi-center validation studies have shown the Afirma Gene Expression Classifier to have a negative predictive value (NPV) of greater than 95% (less than 5% risk of malignancy) on samples identified as benign by the Gene Expression Classifier.5-6 This level of accuracy may allow treating physicians to recommend routine follow-up for their patients with thyroid nodules rather than surgery.
* Indeterminate includes Follicular Lesion of Undetermined Significance (FLUS)/Atypia of Undetermined Significance (AUS) and (suspicious for) Hürthle/Follicular Neoplasm.
NPV = Negative Predictive Value. NPV describes a test’s ability to predict the accuracy of a benign result. The risk of malignancy is 1-NPV.
a.  Offered through Thyroid Cytopathology Partners (TCP). Visit thyroidcytopath.com to learn more.
b.  TCP also issues “Favor Benign” diagnosis. Physicians may choose to repeat FNA or to follow patient sonographically.
c.  Likely Malignant includes Suspicious for Malignancy, Suspicious for Lymphoma, and Malignant.
1.  Lewis CM et al. 2009 Thyroid 19(7) 717-722.
2.  Cooper DS et al. 2009 Thyroid 19(11) 1167-214.
3.  Gharib H, AACE/AME/ETA Thyroid Nodule Guidelines, Endoc Pract. 2010:16(Suppl 1).
4.  Data on File
5.  Haugen BR et al. [Abstract LB137] ITC, Paris, FR 2010 [oral abstract].
6.  Chudova et al. 2010 JCEM 95(12) 5301-5309.
7.  Li H, et al. 2011 J Clin Endocrinol Metab 96(11):E1719-E1726.
8.  Monroe R, et al. [Abstract 1161809] Thyroid 2011; 21(S1): A1-A-110.
9.  Wang C, et al. 2011 Thyroid 21(3):243-251.